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Special Labeling to Ensure Safety

FDA has the option to require special labeling or disclosure statements on the foods containing added substances (whether food additives or GRAS substances) to ensure their safe use. The question of whether to require such labeling has a major policy dimension, as well as a scientific and consumer research dimension, whether the labeling is aimed at the general population or at high-risk subgroups. Such labeling could contribute to a conclusion that certain uses meet the safety standard of “reasonable certainty of no harm” that otherwise might not meet the standard. An example of such labeling that “fixes” a safety issue associated with an added substance is the required statement for aspartame: “Phenylketonurics: Contains phenyalanine.” In this case, there is no safe use of the substance for the subpopulation of phenylketonurics. However, with the safety hazard disclosed by required labeling, the vulnerable subpopulation is alerted, and the rest of the population can consume the substance and benefit from its inclusion in food. FDA could use such labeling as a tool where appropriate in the development of standards for the addition of salt to foods, after the needed exploration of the appropriate nature and impact of such labeling.14

Chapter 6 discusses the available research regarding consumers’ responses to such food label disclosures as well as the labeling associated with the Nutrition Labeling and Education Act (NLEA) of 1990,15 which is discussed below. It suggests the importance of carefully researching consumer response and crafting a framework for such labeling before the provisions are put in place.

Other Sodium-Containing Compounds

The focus on regulatory approaches to reduce sodium intake has centered on salt (sodium chloride) because it is the main contributor of sodium to the American diet. However, as described in Chapter 5, there are a myriad of other compounds that contain sodium and are added to foods. Some of these uses are currently GRAS, and some have been approved as food additives.

Because sodium per se and not just sodium chloride is the concern relative to reducing the risk of elevated blood pressure, the presence of all these

14

Further, another section of the Federal Food, Drug, and Cosmetic Act [Section 403(a) (codified as 21 USC 343(a)) as further defined by Section 201(n) (codified as 21 USC 321(n))] stipulates that food products cannot legally be sold if their labeling is false or “misleading.” The term misleading is further defined as a failure to disclose “facts material with respect to the consequences which may result from the use” of the food. Disclosures can be required to prevent a product’s label from being misleading.

15

Nutrition Labeling and Education Act of 1990, Public Law 101-533, 104 Stat 2353.



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